Trial · NCT00823836
Outcomes62
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 62
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Week 0 (Baseline) in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score at the Final Assessment Point (FAP) (up to Week 24) in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | Per Protocol Set (PPS): participants with exclusion from the Full Analysis Set (FAS) of those violating the study protocol and assessed to be excluded from the assessment of drug efficacy. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2. | scores on a scale | MEAN |
| SECONDARY | Percentage of Responders on the Japanese UPDRS Part III Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | FAP (up to Week 24) | FAS: participants who were progressed to the Non-Inferiority Verification Phase but excluding those who did not have the target indication, those who had not received at least one dose of investigational product, and those whose measured data in efficacy were not available after treatment initiation. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part I total score were not included in the analysis. | scores on a scale | MEAN |
| SECONDARY | Mean Change From Week 0 in the Japanese UPDRS Part II (at On) Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part II (at On) total score were not included in the analysis. | scores on a scale | MEAN |
| SECONDARY | Mean Change From Week 0 in the Japanese UPDRS Part II (at Off) Total Score at Week 24 in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. Only participants who had Off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis. | scores on a scale | MEAN |
| SECONDARY | Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part IV total score were not included in the analysis. | scores on a scale | MEAN |
| SECONDARY | Japanese UPDRS Part I Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP. | scores on a scale | MEAN |
| SECONDARY | Japanese UPDRS Part II (at On) Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP. | scores on a scale | MEAN |
| SECONDARY | Japanese UPDRS Part II (at Off) Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. Only participants who had off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP. | scores on a scale | MEAN |
| SECONDARY | Japanese UPDRS Part III Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP. | scores on a scale | MEAN |
| SECONDARY | Japanese UPDRS Part IV Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP. | scores on a scale | MEAN |
| SECONDARY | Percentage of Responders on the Clinical Global Impression-Improvement (CGI-I) at FAP (up to Week 24) in the Non-Inferiority Verification Phase | FAP (up to Week 24) | FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Responders in Change From Week 0 in Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase | FAP (up to Week 24) | FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Responders in Percent Change From Week 0 in Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase | FAP (up to Week 24) | FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Week 0 in Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis. | hours | MEAN |
| SECONDARY | Mean Change From Week 0 in Percentage of Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis. | percentage of time | MEAN |
| SECONDARY | Mean Percent Change From Week 0 in Percentage of Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis. | percent change | MEAN |
| SECONDARY | Mean Change From Week 0 in Awake Time Spent On at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. Participants who had 0 hour as On time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis. | hours | MEAN |
| SECONDARY | Mean Change From Week 0 in Percentage of Awake Time Spent On at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. Participants who had 0 hour as On time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis. | percentage of time | MEAN |
| SECONDARY | Mean Change From Week 0 in Awake Time Spent On With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. Participants who had 0 hour as On time with troublesome dyskinesias at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis. | hours | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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